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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K252712

510(k) cleared

STIMPOD NMS460 Nerve Stimulator

Algiamed Technologies USA, Inc. · May 28, 2026 · K252712

FDA cleared the STIMPOD NMS460 Nerve Stimulator from Algiamed Technologies USA, Inc. on May 28, 2026 under K252712, a traditional 510(k). The device falls under product code GZJ, Stimulator, Nerve, Transcutaneous, For Pain Relief, regulated at 21 CFR 882.5890 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Aug 27, 2025. The decision came 274 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Algiamed Technologies USA, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252712?

K252712 is the FDA 510(k) for STIMPOD NMS460 Nerve Stimulator, submitted by Algiamed Technologies USA, Inc.. FDA's decision date was May 28, 2026, under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief).

Who makes the STIMPOD NMS460 Nerve Stimulator?

Algiamed Technologies USA, Inc., based in Lake Mary, FL, is the applicant of record for K252712.

How long did the K252712 review take?

FDA received the submission on Aug 27, 2025 and issued its decision on May 28, 2026, 274 days later.

← All decisions in May 2026